POLLINOSAN HAYFEVER TABLETS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Pollinosan Hayfever tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet (250 mg) contains:

Ammi visnaga

Aralia racemosa

Cardiospermum halicacabum

Larrea mexicana

Luffa operculata

Okoubaka aubrevillei

Galphimia glauca

Contains lactose monohydrate.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablet

Slightly yellowish, biconvex tablet with a triangular stamp.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A homeopathic medicinal product used within the homeopathic tradition to relieve the symptoms of hayfever and other forms of allergic rhinitis.

4.2 Posology and method of administration

Adults, the elderly and children over 12 years: Take 2 tablets 3 times daily before meals.

Maximum recommended daily dose is 6 tablets.

This product should not be used in children under 12 years.

For oral use only.

4.3 Contraindications

Hypersensitivity to any of the active ingredients or to any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If the condition worsens, or if symptoms persist for more than 7 days, consult a doctor or qualified healthcare practitioner.

This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

This product is not recommended for use in children under 12 years of age due to a lack of data on safety.

4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

Pregnancy: There is no evidence of the safety of the product in human pregnancy, nor is there any evidence from animal studies.

The use of the product during pregnancy and lactation should be avoided unless under the guidance of a doctor.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

Pollinosan has no influence on the ability to drive or use machines.

4.8 Undesirable effects

Frequency not known

Gastrointestinal disturbances e.g. nausea, stomach upset.

Allergic reactions e.g. rash

If symptoms worsen, or persist for more than 7 days, or if other adverse reactions not mentioned above occur, a doctor, pharmacist or a qualified healthcare practitioner should be consulted.

4.9 Overdose

None known.

5.1

Not applicable.

5.2

Not applicable.

5.3

Preclinical safety data Not applicable.

6.1

Lactose monohydrate

Pregelatinised starch Magnesium stearate

Not applicable.

6.3 Shelf life

60 months.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

7   MARKETING AUTHORISATION HOLDER

8 MARKETING AUTHORISATION NUMBER(S)

NR 13668/0208